Status
Completed
Drug Enforcement D-0320-2023
Lack of sterility assurance
Classification
Class II
Report Date
February 22, 2023
Termination Date
—
Product Information
- Product description
- TPN (a) 115GM/AA, 215GM/DEX, 25GM/LIP 1150ML, (b)90GM/AA, 215GM/DEX, 25GM/LIP 1150ML, (c) TPN AA: 100GM DEX: 105GM 2700ML, (d) TPN AA: 100GM DEX: 105GM LIP: 45GM 2700ML, (e) TPN: AA100GM ; DEX185GM ; LIP50GM IN 1500ML, (f) TPN: AA 150GM ; DEX 220GM ; LIP 45GM IN 2400 ml, (g) TPN: AA 60GM ; DEX 200GM ; LIP 30GM IN 1500 ml, Rx only, use with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
- Product quantity
- 31 bags
- Reason for recall
- Lack of sterility assurance
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- Dispensed to Patients Nationwide.
Location & Firm
- Recalling firm
- Sentara Infusion Services
- Address
-
535 Independence Pkwy Ste 300, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0320-2023
- Event ID
- 91466
- Recall initiation date
- December 27, 2022
- Center classification date
- February 15, 2023
- Code info
- Beyond Use Date: December 24-31, 2022
- More code info
- —